Reward Processing in Cocaine Addiction
|First Received Date ICMJE||December 18, 2009|
|Last Updated Date||May 3, 2013|
|Start Date ICMJE||March 2005|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE||Not Provided|
|Original Primary Outcome Measures ICMJE||Not Provided|
|Change History||Complete list of historical versions of study NCT01036074 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE||Not Provided|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Reward Processing in Cocaine Addiction|
|Official Title ICMJE||Reward Processing in Cocaine Addiction|
- Cocaine affects the brain's ability to process information. However, different people respond to cocaine in different ways, and differences in brain structure and function may affect how cocaine alters brain activity. By using functional magnetic resonance imaging (fMRI) to monitor brain activity during tasks that provide simple rewards, researchers hope to better understand how the brain responds to rewards and how this response is affected by drugs like cocaine.
- Individuals between 18 and 45 years of age who either are cocaine-dependent and not seeking treatment or are healthy volunteers.
The overall objective of this study is to determine the effect that cocaine administration has upon the experience of reward in dependent individuals and the contribution of reward processing (or dysfunction) to the reinforcing effects of cocaine and the recidivism rates noted in cocaine-dependent individuals. The primary goal is to employ functional magnetic resonance imaging (fMRI) to ascertain the function of neural systems that respond to cocaine in human participants and to determine the role that they play in the processing of different types of rewarding stimuli during episodes where individuals are drug-free and those where they are under the acute influence of cocaine.
The experimental population for this investigation will be non-treatment seeking, cocaine-dependent adults (i.e. 18 - 45 years old). A cohort of healthy, drug-free, individuals, matched for age, gender, ethnicity and IQ, will serve as a control group.
This experiment employs a mixed-measures, counter-balanced design. Participants will complete two measures of reward processing (i.e. the revised monetary incentive delay (MID) task and a temporal difference error task (TDE/juice) task) while undergoing BOLD EPI fMRI. The scanning procedure will be repeated for all subjects, such that each participant undertakes 2 sessions. Cocaine-dependent individuals will receive either two injections of cocaine (30 mg/70 kg body weight; intravenous (IV) administration) or two injections of saline during scanning. Within each session, each IV injection will be given approximately 10 minute prior to the start of one of the reward measures. The order of cocaine and saline scans will be randomized and participants will be blind to the experimental condition prior to participation.
The primary outcome measures will be the neural substrates of reward processing and how these differ between cocaine-dependent individuals and controls, and the impact of acute cocaine administration upon brain function associated with reward function.
|Study Type ICMJE||Observational|
|Study Design ICMJE||Not Provided|
|Target Follow-Up Duration||Not Provided|
|Sampling Method||Not Provided|
|Study Population||Not Provided|
|Intervention ICMJE||Not Provided|
|Study Group/Cohort (s)||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Completed|
|Estimated Enrollment ICMJE||100|
|Completion Date||April 2013|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
Participants in both groups must be:
Cocaine-dependent participants must also:
Participants in both groups will be excluded from participation in this study if they:
Cocaine-dependent individuals will also be excluded from participation if:
They have any current or previous history of any major psychiatric disorder other than cocaine dependence, including but not limited to mood, anxiety and psychotic disorders.
They have current dependence on any substance of abuse, other than cocaine or nicotine. However, current or past co-morbid abuse of alcohol, marijuana and past dependence on other substances of abuse will be tolerated in this group.
They have a history of adverse reaction to cocaine, such as cardiac arrhythmia or chest pain.
Control participants will be excluded if they:
|Ages||18 Years to 50 Years|
|Accepts Healthy Volunteers||No|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Location Countries ICMJE||United States|
|NCT Number ICMJE||NCT01036074|
|Other Study ID Numbers ICMJE||999905399, 05-DA-N399|
|Has Data Monitoring Committee||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||National Institute on Drug Abuse (NIDA)|
|Collaborators ICMJE||National Institute of Mental Health (NIMH)|
|Information Provided By||National Institutes of Health Clinical Center (CC)|
|Verification Date||April 2013|
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